FSMA Preventive Controls for Human Food Rule Now Final: What You Need to Know

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Following several years of FDA outreach and industry input, the Food Safety Modernization Act’s Preventive Controls for Human Food rule is now officially final. The rule implements elements from the original proposal in 2013 as well as supplemental proposals since then. Several things have changed as a result.

Key Requirements

Covered facilities must establish and implement a food-safety system that includes an analysis of hazards and risk-based preventive controls. The rule requires a written food-safety plan including:

  • Hazard analysis—identification of known or reasonably foreseeable hazards
  • Preventive controls—ensure hazards requiring a preventive control will be minimized (process, food allergens, sanitation and supply-chain controls)
  • Preventive controls management and oversight—ensure effectiveness of preventive controls, including:
    • Monitoring
    • Corrective actions
    • Verification (product testing, environmental monitoring required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food-safety system)

With the new rule, the FDA has offered a more flexible supply-chain program, laying out requirements for preventive controls when dealing with suppliers. There were also updates and clarifications to current good manufacturing practices, most notably the elimination of non-binding provisions — those that were are now binding.

Compliance dates

Businesses’ compliance dates are staggered based on size:

  • Three years
    • Very small businesses (averaging less than $1 million in annual sales of human food and the market value of human food manufactured, processed, packed or held without sale)
    • Businesses subject to the Pasteurized Milk Ordinance
  • Two years
    • Small businesses (less than 500 full-time employees)
  • One year
    • All other businesses

There are also compliance dates for the supply-chain program.

The FDA is working to offer compliance assistance to facilities to educate and regulate the food industry. It is developing guidance programs on subjects such as hazard analysis, environmental monitoring and food allergen controls. Plans for technical assistance and training are also under way.

If you’d like to learn more about the FSMA, feel free to email me at foodforthought@stellar.net or connect with me on LinkedIn.


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